MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number CXT231412

Device Problem Insufficient Information (3190)

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release specifications.Code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.According to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu) states, adverse events that may occur and / or require intervention include: endoleak and reintervention.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The following information was reported to gore: on (b)(6) 2022, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis.The trunk ipsilateral leg endoprosthesis was inserted from the right side of the patient and deployed its main body and the ipsilateral leg.An aortic extender component was additionally implanted in the proximal side.After the gate cannulation, one contralateral leg component (plc121400) was implanted on the left/contralateral side and another contralateral leg component (plc121400) on the right/ipsilateral side.At the angiography after the placement, it was revealed that no leg component was implanted within the contralateral gate while two legs were implanted within the ipsilateral leg.As treatment, two gore viabahn vbx balloon expandable endoprosthesis (size 8l-79) were implanted above from the bifurcation site of the trunk ipsilateral leg endoprosthesis using the kissing balloon technique and the contralateral gate was coil embolized.After the coil embolization, a leak remained from the contralateral gate, so an iliac extender component (pll161007) and vbx (size8l-59) were placed proximally using the kissing balloon technique and the gate was embolized by n-butyl-2-cyanoacrylate (nbca).Using the kissing balloon techniques, blood successfully flowed through into the right and left sides.Although the leak remained, the procedure was completed.The patient was decided to be monitored.During the gate cannulation of the contralateral gate, the distal ipsilateral leg and contralateral gate were coaxially located and appeared to be cannulated with a wire into the contralateral gate.Reportedly that the angle of fluoroscopy should have been changed for the confirmation. on (b)(6) 2022, this patient underwent a reintervention.Coil embolization was performed on the contralateral gate of the trunk ipsilateral leg endoprosthesis, but the leak was not resolved.Therefore, the patient was opened, and the contralateral gate was surgically ligated.The patient tolerated the procedure.

• Brand Name: GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16079271
• MDR Text Key: 306499835
• Report Number: 3007284313-2022-02283
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CXT231412
• Device Catalogue Number: CXT231412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/30/2022
• Date Device Manufactured: 06/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female